In the past decade, digital technologies have changed almost every aspect of our lives. From technologically advanced phones to homes, there is the smart use of technology in everything. This is also true of the digital health technologies, which can offer solutions that healthcare has been looking for and transform the way clinical trials are conducted.
Featuring for the Cover Story of The Enterprise World’s this issue of the Most Promising Digital Health Solution Providers in 2022 is CliniOps, Inc., a company that is providing an unified platform for hybrid and decentralized clinical trials (DCT).
CliniOps is a Technology and Data Science company for the Life Science Industry. The company helps Pharma and Biotech companies to conduct Clinical Trials (Hybrid & DCT trials) that makes drug trials accessible, inclusive, faster, and cheaper. The technology platform leverages AI, Mobile, Analytics, Cloud, Sensors and Connected Devices.
“We are currently supporting trials in 30+ countries across all Phases, and several therapeutic areas.”
Avik Pal, Founder and CEO, graduated from IIT (Indian Institute of Technology) and comes with a data and technology background. His wife, Dr. Reshmi Pal, who is a physician but later moved into clinical research introduced him to this space. The more he read about this research space, the more it was clear to Avik, that there is a lot of data play involved, especially if you talk about the large global clinical trials.
To get a better understanding of this, he actually participated in a few clinical trials as a healthy volunteer, and found that even in the Silicon Valley, clinical trial sites were conducting trials in a very manual and a paper-based process, using binders, folders, and cup-boards, where stacks of paper records were stored for years, for regulatory purposes.
“Knowing how costly real-estate is in San Francisco, I wished these cub-boards could be replaced by beds for patients. With that motivation, I started CliniOps, to design a platform with cutting edge technology innovation in the conduct of next-generation clinical trials.”
Mr. Yerramalli Subramaniam and Mr. Partha Chakraborty, both alumni of IIT, joined in this journey. They have all known each other for a long time – each took different career paths, that helped bring fresh and unique perspectives with a mission to make the entire clinical trial process seamless, digital and collaborative. CliniOps works with several Top academic institutions, global health foundations, Biotech, Pharma, Med device companies and CROs.
Cutting Through the Complexities
Clinical trial is a complex process and with growing decentralization only increases the complexity. As an outsider looking in, Avik didn’t have to do the ‘unlearning’ of how clinical trials were conducted in the traditional way. This helped him bring new ideas and perspectives with an approach that differentiated CliniOps from its peers.
But since this is a highly regulated and risk-averse industry, adoption to newer ideas and newer technology took time. Avik spoke at several conferences championing the company’s work and ideas and it gradually started gaining momentum.
“We were also invited at the FDA innovation summit that helped the cause. Over time we started getting awarded challenging projects, including a very large 26,000 patient multi-country, multi-lingual clinical trial, conducted on our platform, which was a huge success.”
The Growth Over the Years
Here are a few statistics that show the growth of the company over years.
- Supporting trials in over 30+ countries, across North America, South America, Europe, Asia Pacific and multiple countries across Sub Saharan Africa
- Supporting trials across all phases 1, 2, 3, 4
- Several FDA approved trials conducted on CliniOps platform, and several clinical trials in-flight which are on the regulatory pathway
- Constantly innovated over the years, and have been recognized by top Life Sciences analysts, including being featured by Gartner, in the Hype Cycle for Life Sciences R&D 2019, 2020, 2021
“We are on a mission to make drug trials accessible, inclusive, faster, and cheaper.”
Currently less than 5% of the patient population participates in clinical trials and 95% cannot be reached. CliniOps is a platform that helps with the conduct of remote trials, where patients can be reached from the comfort of their home
If you look at US, less than 2% of the zip codes cater to > 50% of the trials.
Each year, globally about 30,000 new trials are conducted in high income countries Vs only 300 new trials in low income countries (1:100 ratio). CliniOps has developed a platform, that addresses many of these challenges leveraging technology to reach patients who are otherwise not accessible through traditional means. CliniOps helps with diversity and inclusive research in a significant way.
The Products and Services
CliniOps Unified Technology platform offers seamless trial conduct across site-visit, tele-visit, home-visit, lab-visit and more, including data collection from wearables and connected devices. The company also offers comprehensive data services to augment the in-house team, of the sponsors and CROs, throughout study start-up, study conduct and study closeout phases.
During study start-up, their highly experienced team offers study build including configuration of forms, edit checks, workflows, reports, notifications et al., across all modules. A complete validation is also performed with CRF completion guidelines and release notes. During the study conduct phase, clinical data management, query resolution, user management and standard support services are provided. In addition, data reconciliation, DB lock, data transfer, data archival and other services are provided during the study closeout phase. CliniOps also provides, Biostatistics, TLF programming, ADaM, SDTM, and medical writing services.
Study Setup Services
CliniOps offers a comprehensive study setup service. Their customized services are designed to help you configure your trials more efficiently. The platform will not only complement your internal team to achieve your goals but will also ensure transparency and collaboration throughout the duration of your trial.
“We ensure timely study build cycles with early review phases and testing opportunities.”
Subject-matter experts who have experience with everything from simple single arm studies to complex multi-arm randomized global studies will form the core of the study setup team and will ensure that real-world issues are considered. In fact, before the team provides you your study for User Acceptance Testing, it will go through a rigorous quality assurance and clinical review cycle.
Clinical Data Management
CliniOps’ team of experienced professionals can help you in all aspects of clinical data management challenges and collaborate with you in the process of collection, cleaning, and management of subject data in compliance with regulatory standards. The company strives to provide you with error free, valid and statistically sound data for analysis.
“With continuous access to your data and total transparency in the entire process, you stay in complete control of your data.”
CliniOps’ clinical data management specialists will deconstruct your clinical trial protocol into an intuitively designed data capture system that will accurately meet the data management requirements of your study. So, while a team of professionals manages all your data, you spend less time on training and more time running the trial efficiently.
Biostatistics & Statistical Programming
At CliniOps, the team also offers you high-quality, cost-effective, best in class biostatistics services. They have rich experience in biostatistics analysis & reporting. Their biostatistics services offer you accurate data analysis and the ability to comply with regulatory requirements. Their services include Trial Design, Randomization, Statistical Analysis Plan (SAP), Statistical Programming, Tables, Listings and Figures (TLFs) and Clinical Study Report (CSR) generation.
“We have extensive experience in designing, analysing and reporting clinical studies across a broad range of therapeutic areas, supported by robust processes.”
The team’s deep regulatory knowledge & domain expertise in biostatistics services helps you to navigate the complexities of study design, sample size calculation, study randomization, Data Visualization etc.
The Road Ahead
The company has a strong product roadmap ahead. Data Science is heavily under-utilized in this industry, not because there is dearth of great analytics companies, but more because of the lack of great quality data at source, in real-time.
“Currently data is usually days, weeks, or sometimes months old, before it enters the system, which defeats the purpose of the data science models, since your analytics is as good or as bad as the data feeding it.”
The industry is moving in the direction of continuous monitoring of the patients. Unless you are able to collect the data in real-time and analyse the data in real-time, you will miss the safety signals. CliniOps is working on developing such capabilities through industry collaborations and partnerships. CliniOps is also investing in R&D on clinical operational excellence to the next level, and in the process elevating clinical data management to clinical data science.
Mr. Avik Pal – Leading the Way
Avik is the CEO of CliniOps. Before starting CliniOps, Avik worked at NTT DATA. Prior to that, he worked with two successful start-ups, managing global delivery at FocusFrame (acquired by Hexaware Technologies) and Euclid (acquired by Persistent Systems/ SAP).
Avik is passionate about Global Health, Social Entrepreneurship and Impact. He is a Founding Board member at iKure, a social entrepreneurship healthcare start-up, focusing on affordable healthcare for the last mile. He was also the President of ‘IIT Foundation’, Silicon Valley Chapter, the alumni association of Indian Institute of Technology, Kharagpur. Avik is a member of the ‘Fast Company executive Board’, he was also profiled by The Technology Headlines magazine, among ’50 Successful Indian Entrepreneurs in US’. He was also a ‘US Department of State Delegate’, at the Global Entrepreneurship Summit.
Avik holds a B. Tech (Honors) from IIT Kharagpur, and an MBA from University of San Francisco, where he was awarded the ‘McLaren Fellowship.’
In his spare time Avik loves to play or watch sports. He ran multiple half-marathons, is an avid golf player and actively follows tennis, soccer and cricket. He played table-tennis and water-polo during his college days. He also enjoys doodling on the canvas, playing his harmonica and hawaiian guitar. Talking about passion, travelling never fails to excite him. He has travelled to about 50+ countries including an amazing expedition to Antarctica. He lives in California with his wife Reshmi and their son Abhiraj.
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